Dexmedetomidine Facilitate Analgesia

China International Neuroscience Institution

Status and phase: Completed; Phase 4

Conditions: Nerve Block; Lower Limb Fracture

Treatments: Drug: Midazolam; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04675372

IRB-XWAD-202008-12

Details and patient eligibility

About

Pre-clinic evidences showed that DEX produces antinociception by inhibiting the activation of spinal microglia and astrocyte decreasing noxious stimuli evoked release of nociceptive substances and further interrupting the spinal neuron-glia cross talk and regulating the nociceptive transmission under chronic pain condition. in this study, the analgesic efficacy of Dexmedetomidine was evaluated by a new non-invasive nociceptive index (qNOX). In this study, Anagel6000 analgesia monitor was used to quantitatively compare the analgesic efficacy of Dexmedetomidine compared with Midazolam.

Full description

Pre-clinic evidences showed that DEX produces antinociception by inhibiting the activation of spinal microglia and astrocyte decreasing noxious stimuli evoked release of nociceptive substances and further interrupting the spinal neuron-glia cross talk and regulating the nociceptive transmission under chronic pain condition. in this study, the analgesic efficacy of Dexmedetomidine was evaluated by a new non-invasive nociceptive index (qNOX). In this study, Anagel6000 analgesia monitor was used to quantitatively compare the analgesic efficacy of Dexmedetomidine compared with Midazolam.

Enrollment: 181 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged from 18 to 80 years old
• American Association of anesthesiologists (ASA) grade Ⅱ ~ IV
• body mass index (BMI) 18.5-40
• planning undergoing peripheral nerve block

Exclusion criteria

• incomplete effect of nerve block
• Alzheimer's disease
• implanted cardiac pacemakers
• mental illness
• epilepsy
• autonomic nervous system diseases
• projected the duration of the operation was more than 3 hours

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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181 participants in 2 patient groups

Group 1

Experimental group

Description:

Dexmedetomidine group (Group DEX) was given 1.5ug/kg/h Dexmedetomidine continuous infusion Dexmedetomidine group (Group DEX)

Treatment:

Drug: Dexmedetomidine

Group 2

Active Comparator group

Description:

Midazolam group (Group MID) was continuously pumped with 0.05mg/kg/h midazolam

Treatment:

Drug: Midazolam